UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15(D) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of
report (Date of earliest event reported): August 27,
2009
(Exact
Name of Registrant as Specified in Its Charter)
(State or
Other Jurisdiction of Incorporation)
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000-53404
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87-0652870
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(Commission
File Number)
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(IRS
Employer Identification No.)
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3293
Harrison Blvd., Ste. 230, Ogden, UT
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84403
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(Address
of Principal Executive Offices)
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(Zip
Code)
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(Registrant’s
Telephone Number, Including Area Code)
(Former
Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions (see General Instruction A.2.
below):
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item 1.01
Entry into a Material Definitive Agreement.
Effective August 27, 2009, Bio-Path
Holdings, Inc. (the “Registrant”) entered into an exclusive License Agreement
(the “Agreement”) with The University of Texas M. D. Anderson Cancer Center to
develop liposome tumor targeting technology. Bio-Path is currently developing a
neutral-lipid based liposome delivery technology for nucleic acid cancer drugs
(including antisense and siRNA molecules). The new technology, being licensed in
the field of neutral lipid-based liposome delivery of antisense technologies and
FAK siRNA, is projected to enhance the Registrant’s liposome delivery technology
by adding vectors to the liposomes targeted to a receptor that is specifically
over-expressed on a majority of solid and hematological tumors and on 80 percent
of metastatic epithelial tumors. The Registrant believes this liposome
tumor-targeting technology for antisense and FAK siRNA delivery is a highly
promising strategy for treating primary and metastatic cancers.
The historical perspective of cancer
treatments has been drugs that affect the entire body. Advances in the past
decade have shifted to treating the tumor tissue itself. One of the main
strategies in these developments has been targeted therapy, involving drugs that
are targeted to block the expression of specific disease causing proteins while
having little or no effect on other healthy tissue. Nucleic acid drugs,
specifically antisense and siRNA, are two of the most promising fields of
targeted therapy. Development of antisense and siRNA, however, has been limited
by the lack of a suitable method to deliver these drugs to the diseased cells
with high uptake into the cell and without causing toxicity. Bio-Path’s
currently licensed neutral-lipid based liposome technology is designed to
accomplish this. Studies have shown a tenfold to thirtyfold increase in tumor
cell uptake with this technology compared to other delivery methods. The
Company’s first drug with this delivery technology is scheduled to commence a
Phase I clinical trial in the fourth quarter 2009.
The new liposome tumor targeting
technology being licensed will be developed as an extension of the Registrant’s
current delivery technology, with a goal toward more powerfully focusing
delivery of the antisense and FAK siRNA cancer treatments to the tumor tissue.
Adding a vector to the liposome that targets a receptor that is highly expressed
on the surface of tumor cells is expected to drive uptake of the liposomes into
the tumor tissue, enhancing relative deposition in the target tumor tissue. In
animal studies conducted at M. D. Anderson Cancer Center, researchers
demonstrated an ability for vector targeted neutral lipid-based liposomes to
increase transfection efficiency and siRNA molecule uptake fivefold to eightfold
into cancer cells compared to those of untargeted liposomes and controls. These
efficiencies are in addition to the delivery efficiencies noted above from the
core neutral lipid-based liposome delivery technology.
Pursuant to the License Agreement, the
Registrant is obligated to various one time and recurring fees, expenses,
royalties, milestone payments and other compensation and expenses to the
licensor.
Item 9.01 Financial
Statements and Exhibits.
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B.
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Exhibits
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Item 10.1 –
Drug Product Development and Clinical Supply Agreement
(attached)
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Item
99 -- Press Release
(attached)
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SIGNATURES
Pursuant to the requirements of the
Securities Act of 1934, the Registrant has duly caused this report to be signed
on its behalf by the undersigned thereunto duly authorized.
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Dated: September
24, 2009
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BIO-PATH
HOLDINGS, INC.
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By: /s/
Peter Nielsen
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Chief
Executive Officer
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